Porphyromonas Gingivalis and Alzheimer's Disease | NCT02109705

Studies
Porphyromonas Gingivalis and Alzheimer's Disease

NCT02109705

Sponsor

University Hospital Muenster

Status

Completed

Last Update Posted

May 31, 2023Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Alzheimer's Disease
Dementia
Periodontitis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014Actual

Primary Completion Date

Jan 2021Actual

Completion Date

Jan 2021Actual

First Submitted Date

Mar 31, 2014

First Submission Date that Met QC Criteria

Apr 7, 2014

First Posted Date

Apr 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2023

Last Update Posted Date

May 31, 2023Actual

Name	Class
University of Bern	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With this study the investigators would like to analyze the the role of periodontal disease and especially the role of Porphyromonas gingivalis in initiation and progression of Alzheimer's Disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax Antibody Levels against Gingipains	laboratory analysis	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Cmax Beta-Amyloid	laboratory analysis	Baseline

Other Outcomes

Measure	Description	Time Frame
Cmax: Periodontal pathogens	laboratory analysis	Baseline
U enzyme activities	laboratory analysis	Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 40-70
caucasian origin
dementia (Alzheimer's or other dementia)
cognitive healthy (need for spinal anesthesia)

Exclusion Criteria:

use of antibiotics within las 6 months
pregnancy
another illness explaining the symptoms in a better way
smoking (>10 cigarettes)
patients who have a legal custodian

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

60 Patients with Dementia (30 with Alzheimer's and 30 with another Dementia) 30 cognitive healthy patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Laugisch, Dr med dent MAS	Department of Periodontology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Periodontology		Münster		48143	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D003704	Dementia
D010518	Periodontitis

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided